5/18. Ibalizumab uiyk-(TROGARZO)- (Mar 2018)- to treat HIV patients who have limited options
Drug Name:5/18. Ibalizumab uiyk-(TROGARZO)- (Mar 2018)- to treat HIV patients who have limited options
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
Drug Interaction studies
No drug interaction studies have been conducted with ibalizumab-uiyk. Based on ibalizumab-uiyk’s mechanism of action and target-mediated drug disposition, drug-drug interactions are not expected.
Indication:
BRIEF SUMM ARY
IBALIZUMAB- (March 2018)
Indn-To treat HIV patients who have limited options
Comp- Injection: 200 mg/1.33 mL (150 mg/mL) in a single-dose vial. TROGARZO is administered intravenously (IV) as a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every 2 weeks after dilution in 250 mL of 0.9% Sodium Chloride Injection, USP.
ADR- The most common adverse reactions (incidence = 5%) were diarrhea, dizziness, nausea, and rash.
CI- None.
WARNINGS -
Immune Reconstitution Inflammatory Syndrome (IRIS) has been reported in patients treated with combination antiretroviral therapies.
Pat Inform-
Immune Reconstitution Inflammatory Syndrome:
Advise patients that immune reconstitution syndrome has been reported in a patient receiving to inform their health care provider immediately of any symptoms of infection
Important Administration Information
Advise the patient it is important to receive injections every two weeks as recommended by their healthcare professional and not to change the dosing schedule or any antiretroviral medication without consulting their healthcare provider.
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U.S. FDA APPROVED DRUGS DURING 2018
Sr.No- 5
Name of the Drug- Trogarzo
Active Ingredient - Ibalizumab uiyk
Pharmacological Classification-
To treat HIV patients who have limited options
Date of Approval- March 2018
(Ref- FDA approved List 2018)
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TROGARZO safely and effectively. See full prescribing information for TROGARZO.
TROGARZO™ (ibalizumab-uiyk) injection, for intravenous use
Initial U.S. Approval: [2018]
INDICATIONS AND USAGE
TROGARZO, a CD4-directed post-attachment HIV-1 inhibitor, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.
Adverse Reaction:
ADVERSE REACTIONS
The most common adverse reactions (incidence = 5%) were diarrhea, dizziness, nausea, and rash.
Contra-Indications:
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Immune Reconstitution Inflammatory Syndrome (IRIS) has been reported in patients treated with combination antiretroviral therapies.
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
TROGARZO, a CD4-directed post-attachment HIV-1 inhibitor, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.
DOSAGE AND ADMINISTRATION
TROGARZO is administered intravenously (IV) as a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every 2 weeks after dilution in 250 mL of 0.9% Sodium Chloride Injection, USP.
DOSAGE FORMS AND STRENGTHS
Injection: 200 mg/1.33 mL (150 mg/mL) in a single-dose vial.
Patient Information:
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Immune Reconstitution Syndrome
Immune Reconstitution Inflammatory Syndrome:
Advise patients that immune reconstitution syndrome has been reported in a patient receiving TROGARZO and to inform their health care provider immediately of any symptoms of infection
Important Administration Information
Advise the patient it is important to receive TROGARZO injections every two weeks as recommended by their healthcare professional and not to change the dosing schedule of TROGARZO or any antiretroviral medication without consulting their healthcare provider.
Advise the patient to contact their healthcare provider immediately if they stop taking TROGARZO or any other drug in their antiretroviral regimen.
Pregnancy Exposure Registry
Inform patients that there is an antiretroviral pregnancy registry that monitors fetal outcomes of pregnant women exposed to TROGARZO.
Lactation
Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in breast milk
Manufactured by: TaiMed Biologics USA Corp., Irvine, California 92614
US License No. 2057
Distributed by: Theratechnologies Inc., 2015 Peel Street, 5th Floor, Montréal, Québec Canada H3A 1T8
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
Ibalizumab-uiyk is an HIV-1 antiretroviral drug
2. Pharmacodynamics
A clear trend was identified between exposure and response rate for the Phase 2b trial (TMB-202) which studied two different intravenous doses given at two different dosing intervals (every 4 weeks vs. every 2 weeks).
The recommended intravenous dosing regimen consisting of a 2,000 mg loading dose followed by a maintenance dose of 800 mg every 2 weeks was selected on the basis of these results.
3. Pharmacokinetics
Ibalizumab-uiyk administered as a single agent exhibits nonlinear pharmacokinetics. Following single-dose administrations of ibalizumab-uiyk as 0.5 to 1.5-hour infusions, the area under the concentration-time curve increased in a greater than dose-proportional manner, clearance decreased from 9.54 to 0.36 mL/h/kg and elimination half-life increased from 2.7 to 64 hours as the dose increased from 0.3 to 25 mg/kg.
The volume of distribution of ibalizumab-uiyk was approximately that of serum volume, at 4.8 L.
Specific Populations
A population pharmacokinetic analysis was performed to explore the potential effects of selected covariates (age, body weight, sex, baseline CD4+ cell count) on ibalizumab-uiyk pharmacokinetics. The result suggests that ibalizumab-uiyk concentration decreases as body weight increases; however, the effect is unlikely to impact virologic outcome and does not warrant a dose adjustment.
Pediatric/Geriatric Patients:
Ibalizumab-uiyk pharmacokinetics have not been evaluated in pediatric or geriatric patients
Renal/Hepatic Impairment:
No formal studies were conducted to examine the effects of either renal or hepatic impairment on the pharmacokinetics of ibalizumab-uiyk. Renal impairment is not anticipated to impact the pharmacokinetics of ibalizumab-uiyk.
Drug Interaction studies
No drug interaction studies have been conducted with ibalizumab-uiyk. Based on ibalizumab-uiyk’s mechanism of action and target-mediated drug disposition, drug-drug interactions are not expected.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1.Pregnancy Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to TROGARZO during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1–800–258–4263.
Risk Summary
No adequate human data are available to establish whether or not TROGARZO poses a risk to pregnancy outcomes. Animal reproductive toxicology studies with ibalizumab-uiyk have not been conducted.
Monoclonal antibodies, such as ibalizumab-uiyk, are transported across the placenta as pregnancy progresses; therefore, ibalizumab-uiyk has the potential to be transmitted from the mother to the developing fetus.
The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
2.Lactation Risk Summary
The Centers for Disease Control and Prevention recommend that HIV-1-infected mothers in the United States not breastfeed their infants to avoid the risk of postnatal transmission of HIV-1 infection.
No data are available regarding the presence of TROGARZO in human milk, the effects on the breastfed child, or the effects on milk production. Human IgG is present in human milk, although published data indicate that antibodies in breast milk do not enter the neonatal or infant circulation system in substantial amounts.
Because of the potential for HIV-1 transmission, instruct mothers not to breastfeed if they are receiving TROGARZO.
3. Pediatric Use
The safety and effectiveness of TROGARZO in pediatric patients have not been established.
4. Geriatric Use
No studies have been conducted with TROGARZO in geriatric patients.
